Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: - . Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis - Inflammatory joint disease including rheumatoid arthritis . - . Correction of functional deformity including congenital hip dysplasia - . Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture - . Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus, Spartan, and World Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only. Signature Orthopaedics' Evolve. Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only. Signature Orthopaedics' SignaSure Insert is indicated for use with a cementless Signature Orthopaedics' Logical Acetabular Cup to provide dual mobility articulation. Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as: - Acute femoral head or neck fracture . - Fracture dislocation of the hip . . . - . Avascular necrosis of the femoral head - . Non-union of femoral neck fractures - . Certain high subcapital and femoral neck fractures in the elderly - Degenerative arthritis involving only the femoral head
Device Story
World Hip System comprises circular tapered femoral stem, metal-backed cementless acetabular cups, and highly cross-linked polyethylene liners. Stem features longitudinal ribs; manufactured from forged Ti6Al4V alloy (ASTM F136); grit-blasted body; 12/14 taper connection. Acetabular cups available in three-hole configuration for supplemental screw fixation. Liners available in neutral, 10°, and 20° hooded options to address stability. Device used in total hip arthroplasty; implanted by orthopedic surgeons in clinical/OR settings. System provides mechanical replacement of hip joint; restores joint function; addresses stability via liner geometry. Compatibility with previously cleared femoral heads maintained via standardized taper.
Clinical Evidence
Bench testing only. No clinical data provided. Performance verified via ISO-standardized testing: ISO 21535 (range of motion), ISO 7206-4 (stem fatigue), ISO 7206-6 (neck fatigue), ISO 7206-10 (head disassembly/static burst), ISO 7206-13 (rotational stability), plus fretting corrosion, shell stiffness, and liner-shell assembly/disassembly/torsion/lever-out/impingement testing.
Indicated for patients requiring hip joint replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), inflammatory joint disease (rheumatoid arthritis), functional deformity (congenital hip dysplasia), traumatic injury (traumatic arthritis, femoral head/neck fracture), or failed previous hip surgery. Constrained liners indicated for high dislocation risk (prior dislocation, bone loss, laxity, neuromuscular disease). UniPolar/BiPolar heads indicated for hemi-hip arthroplasty in femoral head/neck fractures or pathologies.
Regulatory Classification
Identification
A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.
Predicate Devices
Signature Orthopaedics Logical G-Series Acetabular Cup and Liner (K121297)
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September 21, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Signature Orthopaedics Pty Ltd. Declan Brazil Managing Director 7 Sirius Road Lane Cove, NSW 2066 Australia
Re: K201278
Trade/Device Name: World Hip Stem, World Cup, World Liner Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: MEH, LPH, KWZ Dated: August 31, 2020 Received: September 4, 2020
Dear Declan Brazil:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vesa Vunigi, M.S. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### 1 INDICATIONS FOR USE STATEMENT
510(k) Number (if Known): K201278
Device Name: World™ Hip System
Indications For Use:
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:
- . Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
- Inflammatory joint disease including rheumatoid arthritis .
- . Correction of functional deformity including congenital hip dysplasia
- . Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
- . Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus, Spartan, and World Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.
Signature Orthopaedics' Evolve. Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.
Signature Orthopaedics' SignaSure Insert is indicated for use with a cementless Signature Orthopaedics' Logical Acetabular Cup to provide dual mobility articulation.
Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
- Acute femoral head or neck fracture .
- Fracture dislocation of the hip .
.
.
- . Avascular necrosis of the femoral head
- . Non-union of femoral neck fractures
- . Certain high subcapital and femoral neck fractures in the elderly
- Degenerative arthritis involving only the femoral head
- Prescription Use: Yes Over-The-Counter Use: No AND/OR (Part 29 CFR 801 Subpart D) (Part 29 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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# 510(K) SUMMARY
| Manufacturer: | Signature Orthopaedics Pty Ltd<br>7 Sirius Road<br>Lane Cove, NSW 2066<br>Australia<br><br>Signature Orthopaedics Europe Ltd<br>Unit A, IDA Business & Technology Park Garrycastle<br>Athlone Westmeath N37 DY26<br>IRELAND |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade<br>Name: | World™ Hip System |
| Common Name: | Cementless Hip Replacement Prosthesis |
| Contact: | Dr. Declan Brazil<br>Managing Director of Signature Orthopaedics |
| Prepared By: | Signature Orthopaedics Pty Ltd<br>7 Sirius Road<br>Lane Cove, NSW 2066<br>Australia<br>Phone: +61 (2) 9428 5181<br>Fax: +61 (2) 8456 6065 |
| Date Prepared: | 8th of May 2020 |
| Classification: | Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymer<br>semi-constrained cemented or nonporous uncemented<br>prosthesis. (MEH)<br><br>Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal<br>semi-constrained porous-coated uncemented prosthesis (LPH)<br><br>Class II per 21 CFR 888.3310: Hip joint metal/polymer<br>constrained, cemented or uncemented prosthesis (KWZ) |
| Predicate Devices: | Primary Predicate<br>• Signature Orthopaedics Logical G-Series Acetabular<br>Cup and Liner (K121297)<br><br>Reference Predicate<br>• Zimmer Wagner Cone Prosthesis® Hip Stem (K113556)<br>• Signature Orthopaedics Logical XLPE 20° Hooded<br>Liner (K153131) |
Additional Predicate
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- Signature Orthopaedics Pegasus Stem (K133370)
- Smith & Nephew's R3 Acetabular Cup (K061253)
## Device Description:
Signature Orthopaedics' World™ Hip Stem is a circular tapered stem with longitudinal ribs intended for single use and cementless fixation in total hip arthroplasty. The stem is manufactured from forged Ti6Al4V alloy as per ASTM F136. It features a grit blasted body and a 12/14 taper connection with the trunnion surface roughness as Rz 2.5, which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components.
Signature Orthopaedics' World™ Acetabular Cups are metal backed cementless acetabular cups with highly cross-linked polyethylene liner intended for use in total hip arthroplasty. The shells are available in a three hole configuration, which allows use of supplemental bone screws for supplemental fixation. The World™ Acetabular Cups are compatible with WorldTM Liners.
Signature Orthopaedics' World™ Liners are designed to articulate with a femoral head of appropriate diameter. The liners are available in neutral, 10° hooded and 20° hooded, allowing the option to address potential joint stability concerns.
## Indications for Use:
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:
- Non-inflammatory degenerative joint disease including osteoarthritis or . avascular necrosis
- Inflammatory joint disease including rheumatoid arthritis .
- . Correction of functional deformity including congenital hip dysplasia
- . Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
- . Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus, Spartan, and World™ Hip femoral stems, SignaSure Cementless Cups, Logical and WorldTM Acetabular Cups are intended for cementless fixation only.
Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.
Signature Orthopaedics' SignaSure Insert is indicated for use with a cementless Signature Orthopaedics' Logical Acetabular Cup to provide dual mobility articulation.
Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement.
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The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
- . Acute femoral head or neck fracture
- . Fracture dislocation of the hip
- . Avascular necrosis of the femoral head
- Non-union of femoral neck fractures ●
- . Certain high subcapital and femoral neck fractures in the elderly
- . Degenerative arthritis involving only the femoral head
## Summary of Technological Characteristics:
The subject devices share the same characteristics and the predicate devices as follows:
- The World™ Hip System is intended for cementless fixation which is the same . intended use as one or more of the predicate devices.
- . The World™ Hip System has the same indications for use as the predicate devices.
- . The World™ Hip System has the same manufacturing route as the predicate devices.
- . The World™ Hip System is manufactured from the same materials as the predicate devices.
- . The World™ Hip System has the same body contact as the predicate devices.
- . The World™ Stem's taper connection is identical to Signature Orthopaedics' Pegasus Stem.
- . The World™ Acetabular Cup has the same coating as Signature Orthopaedics' Logical G-Series Acetabular Shell.
- . The World™ Hip System has the same shelf life as Signature Orthopaedics' Pegasus Stem, Logical G-Series Acetabular Cup and Liner, and Logical XLPE Liners.
- . The World™ Hip System has the same sterilization process as Signature Orthopaedics' Pegasus Stem, Logical G-Series Acetabular Cup and Liner, and Logical XLPE Liners.
The following are the technological differences between the World™ Hip System and its predicate devices:
- . Some of the World™ Hip System's design features differ from the predicate devices.
- . The World™ Stem's trunnion surface finish differs from Signature Orthopaedics' Pegasus Stem.
## Performance Testing:
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the World™ Hip System are adequate for anticipated in-vivo use. Nonclinical testing carried out included:
- . Range of motion testing as per ISO 21535
- Stem fatigue testing as per ISO 7206-4
- . Neck fatigue testing as per ISO 7206-6
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- Head disassembly testing as per ISO 7206-10
- . Head rotational stability testing as per ISO 7206-13
- . Head static burst testing as per ISO 7206-10
- Head fatigue and static burst test post fatigue testing
- . Fretting corrosion testing
- . Shell stiffness testing
- . Shell and liner range of motion testing
- . Articular surface wear testing
- . Liner-shell assembly/disassembly testing
- Liner-shell torsion testing
- . Liner lever out testing
- Liner impingement testing
## Substantial Equivalence Conclusion:
Signature Orthopaedics' World™ Hip System has the same intended use, indications for use, material and similar design features as Zimmer Wagner Cone Prosthesis® Hip Stem (K113556), Signature Orthopaedics Pegasus Stem (K133370), Signature Orthopaedics Logical G-Series Acetabular Cup and Liner (K121297), Signature Orthopaedics Logical XLPE 20° Hooded Liner (K153131), Smith & Nephew's R3 Acetabular Cup (K061253) and non-clinical testing support the substantial equivalence claim.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
